Phase I Clinical Trial Department
Beijing, Beijing Municipality, 100005, China
NCT Number: NCT03316976
The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100005, China
The drug being tested in this study is called Dexlansoprazole. This study will assess the pharmacokinetics, safety and tolerability of a single oral dose of Dexlansoprazole 30 mg and 60 mg delayed-release capsules in healthy participants.
The study will enroll approximately 40 participants, 20 participants in each parallel arm. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
All participants will be asked to take single dose of study drug on Day 1.
This single center trial will be conducted in China. The overall time to participate in this study is approximately 40 days. Participants will be contacted by telephone or will make a final visit to the clinic 5 to 10 days after receiving their last dose of study drug for a follow-up assessment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dexlansoprazole delayed-release capsule.
Other names: TAK-390 Modified Release (TAK-390MR) dexlansoprazole
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Takeda
Industry
A Phase 1, Single-Center, Open-Label, 2-Arm Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 mg and 60 mg Delayed-Release Capsules in Healthy Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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